What is the purpose of this study?
This phase I trial studies the side effects and best dose of lenalidomide when given together with monoclonal antibody with or without isotretinoin in treating younger patients with refractory or recurrent neuroblastoma. Drugs used in chemotherapy, such as lenalidomide and isotretinoin, work in different wants to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as monoclonal antibody Ch14.18, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving more than one drug (combination chemotherapy) together with monoclonal antibody therapy may kill more tumor cells.
What is involved?
This is a
dose-escalation study of lenalidomide.
lenalidomide orally (PO) once daily (QD) on days 1-21, monoclonal antibody
Ch14.18 IV over 10 hours on days 8-11, and isotretinoin PO twice daily (BID) on
days 15-28 of dose levels 2-5. Treatment repeats every 28 days for up to 6
courses in the absence of disease progression or unacceptable toxicity.
After completion of
study treatment, patients are followed up periodically.